Drug Development Process

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1 Drug Development Process Original Arthur: Addie D. Anderson CRB Consulting Engineers, Inc.

2 Overview Important milestones establishing our current system of regulations Step-by-step overview of the drug development process Fast-track drug development More Information

3 Milestones 1800s U.S. became the world s dumping ground for counterfeit, contaminated, diluted, and decomposed drug materials. U.S. Customs Laboratories were established to administer the Import Drugs Act of Mission: Enforce purity and potency standards

4 State of Food and Drug Supply Late 1800s Agricultural to industrial economy Principle means of refrigeration ICE Unpasteurized milk Cows weren t tested for TB Pioneers of bacteriology just starting string of victories over infectious diseases Kick-a-poo Indian Sagwa Warner s Safe Cure for Diabetes Opium, morphine, heroin, and cocaine no restrictions or labeling

5 Medicine Men vs Circus

6 Pure Food and Drug Act of 1906 Prohibited interstate commerce of misbranded and adulterated foods and drugs. Allowed for seizure and criminal penalties. Did not address: Food or drug standards False advertising Inspection of food and drug facilities. Enforced by Division of Chemistry

7 1937 Elixir of Sulfanilamide Liquid form of Sulfanilamide produced using diethylene glycol as solvent. Diethylene glycol = Antifreeze Administered to mostly children to treat streptococcal infections. Existing laws did not require any kind of pharmacological studies demonstrating that a drug is safe. 107 people died.

8 1938- Food, Drug and Cosmetic Act Extended control to cosmetics and therapeutic devices. Required new drugs to be demonstrated as safe before marketing. Eliminated requirement to prove intent to defraud in drug misbranding cases (fraudulent claims). Provided standards and safe tolerances. Authorized factory inspections.

9 1961- Thalidomide Crisis Hailed as a wonder drug for sleeplessness. Relieved many morning sickness symptoms in pregnant women. Unknown that Thalidomide crossed the placental wall. Catastrophic results: Peripheral neuritis nerve disorder Birth defects deafness, blindness, disfigurement, cleft palette, internal defects, phocomelia

10 1962- Kefauver-Harris Amendments Drug Manufacturers were required to prove drug effectiveness and safety to FDA before marketing. Advertisements must show complete info on benefits and risks. Adverse effects must be reported to the FDA. Since 1962, thousands of drugs have been removed from the market because of these amendments.

11 Overview of Development Process Drug Discovery Screening Pre-Clinical Testing IND Application Phase I Clinical Trials Phase II Clinical Trials Phase III Clinical Trials New Drug Application (NDA) / Biologics License Application (BLA) Phase IV and Beyond

12 Therapeutic Drug Discoveries (R & D Careers: Scientists, Management, Finance, Accounting, HR) Determine target disease. Develop hypothesis for a mechanism of treatment. Use CAD and 3-D modeling software to begin evaluating hypothesis. Determine feasibility of producing and evaluating the selected compound.

13 Screening (Careers: Scientists, Management, Finance, Accounting, HR, Quality Assurance/Control, Regulatory) Combination Chemistry Make many possible compounds at one time. Focus on quantity of possible compounds, not purity of each. High Throughput Screening Test hundreds at a time for activity. Process requires serious technology. 1 in 10,000 makes it to the market.

14 Pre-Clinical Testing (Careers: Scientists, Management, Finance, Accounting, HR, Quality Assurance/Control, Regulatory, Vet Med) Evaluate acute and short term toxicity in animals (one rodent, one nonrodent). Dose at increasingly high levels to induce toxicity. Determine lethal dose. Dose at normal levels for short and long term. Assess how drug is absorbed, distributed, metabolized, and excreted in animals.

15 Investigational New Drug (IND) Application (Careers: Quality Assurance/Control, Regulatory people who love to write and document in detail, Legal) Request submitted to FDA to allow human exposure to the experimental drug. IND is an ongoing file at FDA containing data on drug as it passes through the development process. Inexperienced companies often hire consultants to help.

16 Clinical Trials Preclinical Phase I Phase II Phase III FDA Phase IV Years Total Test Population Laboratory and Animal Studies healthy volunteers patient volunteers 1,000-3,000 patient volunteers Purpose Assess safety and biological activity File IND with FDA Determine safety and dosage Evaluate effectiveness, look for side effects Confirm effectiveness, monitor adverse reactions for long term use File NDA with FDA Review process / approval Additional postmarketing testing Success Rate 5,000 compounds evaluated 5 enter clinical trials 1 approved

17 Phase I Clinical Trials (Careers: Scientists, Management, Finance, Accounting, HR, Quality Assurance/Control, Regulatory, Medical) Begin 30 days after submission of IND providing FDA has not placed a clinical hold on development healthy subjects Duration: 1 year Cost: $100,000 - $1,000,000 Determine bioavailability. Determine side effects associated with increasing doses. Gain early evidence on effectiveness.

18 Phase II Clinical Trials (Careers: Scientists, Management, Finance, Accounting, HR, Quality Assurance/Control, Regulatory, Medical) Not necessary to consult with FDA to begin Phase II. Assess a drug s effectiveness in treating a particular disease or medical condition. Safety and side effects are monitored patient volunteers Duration: 2 years Cost: $ million Less than 1/3 of INDs survive Phase II.

19 Phase III Clinical Trials (Careers: Scientists, Management, Finance, Accounting, HR, Quality Assurance/Control, Regulatory, Medical) Company must consult with the FDA before beginning Phase III. 1,000-3,000 patient volunteers Multiple testing sites Duration: years Cost: $ million Confirm effectiveness and safety of drug.

20 New Drug Application (NDA) / Biologics License Application (BLA) (Careers: Quality Assurance/Control, Regulatory people who love to write and document in detail, Legal, Pharmacists, Statisticians) Formal proposal for the FDA to approve a new drug for sale in the U.S. Must provide sufficient evidence for the FDA to decide: Drug is safe and effective. Benefits outweigh the risks. Proposed labeling is appropriate. Manufacturing methods and controls maintain drug identity, strength, quality, and purity.

21 NDA / BLA Review Process (Careers: Quality Assurance/Control, Regulatory people who love to write and document in detail, Legal, Pharmacists, Statisticians) Biologics Center for Biologics Evaluation and Research (CBER) All other drugs Center for Drug Evaluation and Research (CDER)

22 NDA Review Process (Careers: Quality Assurance/Control, Regulatory people who love to write and document in detail, Legal, Pharmacists, Statisticians) Medical - clinical protocols, safety Biopharmaceutical - absorption, distribution, metabolism, and excretion Pharmacology - toxicity, therapeutic value Chemistry - chemical properties Microbiology - anti-infective drugs Statistical - results must be significant

23 Registration and Market Launch (Careers: Marketing and Sales) NDA must be approved. Must prove to FDA that you can safely produce drug. Pre-approval inspection 3 production batches Development group justifies development process

24 For More Information BioPharm Guide to Biopharmaceutical Development

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